Ketamine HCl 50mg per 5mL — Class II drug recall D-0373-2025
Ongoing recall by Denver Solutions, LLC DBA Leiters Health, reported 2025-04-30, distributed nationwide. Lack of Assurance of Sterility: Leaking/damaged syringes.
| Recall number | D-0373-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Denver Solutions, LLC DBA Leiters Health, Englewood, CO, United States |
| Recall initiated | 2025-03-31 |
| Classified | 2025-04-18 |
| Reported by FDA | 2025-04-30 |
| Distributed | Nationwide (US) |
| Quantity | 49,830 syringes |
| Reason classes | sterility, packaging |
| NDC | 71449-0068-11 |
| Lot numbers | 2530019, 2530053 |
| Expiration dates | 2025-07-10, 2025-07-19 |
Product
Ketamine HCl 50mg per 5mL (10 mg per mL), 5mL Single Dose Syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112.NDC: 71449-068-11
Reason for recall
Lack of Assurance of Sterility: Leaking/damaged syringes.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0373-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.